Latest news with #digitalpathology
National Post
7 days ago
- Business
- National Post
Pramana Receives Health Canada Authorization for Digital Pathology Scanners
Article content CAMBRIDGE, Mass. — Pramana, an AI-enabled health tech company modernizing the pathology sector, today announced it has received Health Canada Medical Device Licenses for its flagship digital pathology scanners, the SpectralM and SpectralHT Cubiq systems. The approval authorizes Pramana to import, market, and sell its devices in Canada, expanding access to its advanced imaging and workflow solutions. Article content Health Canada authorization is required to commercialize Class II medical devices and affirms the product's safety, effectiveness, and quality. The approval opens the door for Pramana to support Canadian hospitals, pathology labs, and research institutions, helping modernize diagnostic workflows with scalable, AI-powered digital pathology tools. This recognition marks a critical step in Pramana's international expansion, building on its growing regulatory footprint. Article content 'Receiving Health Canada authorization is a major milestone in our commercialization strategy,' said Prasanth Perugupalli, Chief Product Officer at Pramana. 'It reflects the strength of our product development, quality, and regulatory readiness, and it opens the door to expanding access to our technology in a market known for strong clinical and academic institutions.' Article content Pramana's scanners are designed to digitize a wide range of pathology slides, producing high-resolution whole-slide images with automated quality control and AI-powered decision support. The platform supports both FFPE tissue and Liquid Based Cytology (LBC) samples prepared using methods such as the ThinPrep® Pap test (Hologic) and BD SurePath™ (Becton Dickinson). Unlike most digital pathology systems focused solely on anatomic pathology, Pramana expands digital workflows to include hematopathology, microbiology, and cytology, delivering flexibility across all major slide types. Article content 'Our research at the University of Toronto highlights the need for adaptable platforms that can manage these technical demands while still supporting routine histology and cytology workflows,' said Dr. Carlo Hojilla, Consultant Pathologist at the University of Toronto. 'Pramana's technology meets that standard, and its Health Canada authorization reflects both its clinical utility and the rigorous quality required for widespread adoption.' Article content Prior to receiving Health Canada authorization, Pramana secured Medical Device Single Audit Program (MDSAP) certification, a requirement that validated its quality management system and streamlined regulatory access in Canada, the United States, Brazil, Australia, and Japan, highlighting Pramana's commitment to modernizing digital pathology worldwide. Article content To discover how Pramana's whole-slide imaging solution can help healthcare organizations across Canada, visit Article content About Pramana, Inc. Article content Pramana is a health tech company transforming digital pathology with AI-powered imaging solutions that support seamless adoption across labs, health systems, and medical centers. Pramana's Spectral scanners deliver industry-leading image quality and unprecedented accuracy. Built-in AI algorithms and automated quality control streamline workflows, increase efficiency, and capture previously undetectable tissue features, empowering pathologists with the tools needed to improve clinical diagnostics and research. The company is headquartered in Cambridge, Mass. For more information, visit Article content Article content Article content Article content Article content Article content
Zawya
21-07-2025
- Health
- Zawya
Roche helps Egypt expand digital pathology and AI diagnostics
Egypt - Roche Diagnostics is supporting Egypt's expansion of digital pathology and the integration of artificial intelligence into its public health system to improve the speed and accuracy of diagnoses, particularly in underserved regions, a company official said. The initiatives are being rolled out in partnership with the Ministry of Health and the Universal Health Insurance (UHI) system, according to Liliane Kanaan, North Africa Lead and General Manager for Egypt at Roche Diagnostics. Egypt is one of the first countries in Africa to adopt digital pathology at scale. The technology digitises tissue samples, allowing them to be viewed and analysed remotely. 'By reducing diagnostic turnaround times and enabling telepathology, this innovation will improve both the speed and equity of care delivery,' Kanaan said. 'In underserved communities, digital pathology will facilitate timely first opinions, helping patients receive a diagnosis locally without the need for extensive travel.' For more complex cases, the system allows for rapid second opinions from national or international experts. 'This significantly decreases the travel time and physical burden on both patients and healthcare professionals, while also accelerating diagnosis and treatment planning,' Kanaan added. Roche is also collaborating with national stakeholders to integrate AI into diagnostic workflows by deploying digital pathology scanners and AI-powered tools to modernise hospital pathology laboratories. Kanaan said this helps reduce the burden on healthcare professionals and directly addresses a critical skills gap. 'Notably, this solution directly addresses the severe shortage of pathologists across Africa, where statistics reveal there is approximately one pathologist for every one million people—compared to a ratio of about 1 to 25,000 in countries like the United States and United Kingdom,' she said. The company, which has operated in Egypt for over two decades, has been involved in several national health programmes. Kanaan cited collaborations that have contributed to national health outcomes, including Egypt's Hepatitis C elimination campaign. 'Roche played a key role in deploying national screening efforts, contributing to Egypt's recognition as a WHO Golden Tier country for HCV elimination—an achievement that reflects both the scale and effectiveness of the programme,' she stated. Other past partnerships include supporting the national blood safety strategy with Nucleic Acid Testing (NAT) technology at the National Blood Transfusion Center and providing over two million tests during the early stages of the COVID-19 pandemic. The company continues to support the Presidential Breast Cancer Initiative, launched in 2019, which has screened more than 30 million women to date. Aligning with national priorities like the Presidential Women's Health Initiative ensures innovation addresses the population's most pressing needs, Kanaan said. As part of this, Roche supported the upgrade of more than 26 public pathology laboratories across Egypt. 'These 26 upgraded sites enabled us to deliver over 20,000 full breast cancer diagnostic panels, an essential step in defining effective treatment plans for patients,' she said. Roche is also participating in the national cervical cancer early detection campaign, which has screened more than 20,000 women in collaboration with the Ministry of Health and several non-governmental organisations (NGOs). To meet the region's specific needs, Kanaan said the company localises its solutions by engaging with stakeholders including the Ministry of Health, UHI, military hospitals, academic institutions and NGOs. This involves providing comprehensive solutions that go beyond product sales to include capacity-building programmes, lab software and health consultancy services tailored to local infrastructure and regulations. © 2024 Daily News Egypt. Provided by SyndiGate Media Inc. (
Yahoo
04-07-2025
- Health
- Yahoo
Versailles Hospital Center adopts digital pathology platform
The Versailles Hospital Center has begun a digital pathology transformation by selecting Tribun Health's CaloPix imaging platform. This move is a significant step in modernising the French public healthcare system's diagnostic services and integrating artificial intelligence (AI) into pathology. The implementation of CaloPix within the pathology department is set to streamline primary diagnostics and interdisciplinary collaboration. Tribun Health CEO Jean-François POMEROL said: 'This choice reflects a shared commitment to innovating for more effective, collaborative, and patient-centered healthcare.' Tribun Health's platform has a user-friendly interface and flexibility, catering to the dynamic requirements of hospital infrastructures. It is designed to be open and interoperable, allowing it to integrate with the hospital's digital strategy. This initiative is in line with the Versailles Hospital Center and GHT 78 Sud's digital objectives, which are coordinated with GHT Nord. It contributes to a national effort to upgrade and digitise healthcare facilities. Versailles Hospital Center is GHT 78 Sud's supporting institution. Versailles Hospital Center Pathology Department head Dr Claire GLASER said: 'The selection of CaloPix is fully aligned with our digital transformation strategy. We were impressed by the solution's user-friendliness, performance, and the quality of support offered by Tribun Health's teams. 'This project, developed in collaboration with the GHT Yvelines Nord, marks a key step for the future of our specialty in the region, particularly regarding AI and collaborative work. It also enhances our integration into APHP's expert networks equipped with the same software.' Tribun Health uses data-driven technology and AI to improve precision and minimise turnaround times to assist laboratories and hospitals in transitioning from glass slide pathology to complete digital solutions. "Versailles Hospital Center adopts digital pathology platform" was originally created and published by Hospital Management, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Associated Press
30-06-2025
- Business
- Associated Press
PathAI Receives FDA Clearance for AISight® Dx Platform for Primary Diagnosis
BOSTON, June 30, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight® Dx *—its digital pathology image management system—for use in primary diagnosis in clinical settings. Building on the initial 510(k) clearance for AISight Dx(Novo) in 2022, this latest milestone underscores the platform's continuous innovation and PathAI's commitment to delivering enhanced capabilities as the product evolves. The FDA decision also included a Predetermined Change Control Plan (PCCP), enabling PathAI to validate and implement specified major changes such as additional displays, scanners, file formats and browsers into AISight Dx without requiring additional 510(k) submissions. This proactive regulatory alignment accelerates future software updates and hardware integrations, allowing faster innovation while ensuring continued FDA compliance. AISight Dx is a cloud-native digital pathology platform designed to maximize efficiency in anatomic pathology workflows. From intelligent case management to high-performance slide review and seamless live collaboration, AISight Dx helps labs accelerate turnaround times and optimize pathologist productivity. With integrated image management, synchronized multi-slide navigation, and robust annotation tools, the platform eliminates manual bottlenecks and supports faster, more consistent diagnoses. Designed for interoperability, compliance, and scale, AISight Dx empowers anatomic pathology labs, hospital systems, and academic medical centers to modernize operations and deliver high-quality patient care with confidence. 'Digital pathology is the future of diagnostic medicine, empowering pathologists to work more efficiently and collaborate quickly without being limited to physical specimen review,' said Andy Beck, M.D., Ph.D., CEO of PathAI. 'This 510(k) clearance showcases our commitment to quality and scientific rigor at PathAI and provides us a way forward to continually enhance our AISight Dx IMS.' Learn more about AISight Dx here. * AISight® Dx is FDA-cleared (K243391) for primary diagnosis in the US with the Hamamatsu NanoZoomer® S360MD and Leica Aperio® GT 450 DX slide scanners, and is CE‑IVD–marked for primary diagnosis in the EEA, UK, and Switzerland. About PathAI PathAI is a leading provider of AI-powered pathology solutions that aim to improve the accuracy of histology assessment and accelerate drug development. PathAI's platform leverages advanced artificial intelligence to analyze and interpret pathology images, providing valuable insights to pathologists, researchers, and pharmaceutical companies. PathAI is headquartered in Boston, MA. For more information, please visit and follow us on LinkedIn. Company Contact Liz Storti Chief People Officer [email protected] Media Contact Owen Blaschak LifeSci Communications [email protected]
Globe and Mail
18-06-2025
- Business
- Globe and Mail
Digital Slide Scanners Market Projected to Reach USD 397.1 Mn by 2032, Growing at CAGR of 12.82%
Digital Slide Scanners Market, By Product Type (Automated Digital Slide Scanner, Manual Digital Slide Scanners, Portable Scanners, and Desktop Scanners), By Technology (Brightfield Scanners and Fluorescence Scanners), By Capacity (Scanner 1-60 slides capacity and Scanner 61-299 slides capacity), By Application (Clinical Diagnostics, Scientific Research, and Medical Diagnostics), By End User (Hospitals & Clinical Pathology Labs, Biopharmaceutical & Biotech Companies) Digital Slide Scanners Market Insights The digital pathology industry is experiencing accelerated digitization as laboratories adopt high-resolution imaging for faster diagnostics. Our proprietary research reveals how the Digital Slide Scanners Market is reshaping workflow efficiencies and driving business growth through data-backed market insights. The Global Digital Slide Scanners Market size is estimated to be valued at USD 170.7 Mn in 2025 and is expected to reach USD 397.1 Mn by 2032, exhibiting a compound annual growth rate (CAGR) of 12.82% from 2025 to 2032. This market forecast underscores robust market growth and expanding market opportunities across clinical, research, and educational segments. Request Sample Copy of this Report (Use Corporate eMail ID to Get Higher Priority) at: Market Key Takeaways: Regions: • North America: Early adoption of digital pathology solutions fuels industry size expansion. • Latin America: Rising research funding accelerates market development. • Europe: Stringent regulatory approvals drive quality enhancements in scanners. • Asia Pacific: Growing cancer diagnostics demand boosts scanner deployments. • Middle East: Healthcare infrastructure upgrades open market opportunities. • Africa: Limited access spurs demand for cost-effective, portable systems. Market Segmentation: • By Product Type: – Compact Scanners: Ideal for small clinics and point-of-care imaging. – High-Throughput Scanners: Used in large pathology labs handling >1,000 slides/day. • By Application: – Clinical Research: Supports oncology trials with 40% year-on-year throughput increase in 2024. – Academic Institutions: Enhances teaching with digital slide archives and remote learning. Growth Factors • Rising incidence of cancer diagnoses worldwide—projected 24% increase by 2025—drives scanner installations. • Integration of AI modules into slide scanners escalated by 35% in 2024, boosting diagnostic accuracy and market share for early adopters. • Government initiatives in Asia Pacific increased digital pathology funding by USD 12 Mn in 2025, underpinning market growth and market dynamics. Book the Latest Edition of this Market Study Get Up to 25 % Discount: Market Trends • Cloud-based slide management solutions grew 50% in annual revenue in 2024, shaping market trends toward SaaS adoption. • Hybrid scanners combining brightfield and fluorescence modes saw a 28% shipment rise in 2024, enhancing multiplexed biomarker analysis. • Miniaturized 'smart' scanners with embedded GPU processors emerged in 2025, reducing scan times by 20% and expanding market scope. Actionable Insights • Production Capacity: Leading manufacturers increased output by 22% in 2024 to meet 15,000-unit global demand. • Pricing: Average digital slide scanner price declined by 8% from 2023 to 2025, broadening affordability in mid-tier markets. • Exports: Exports to emerging APAC markets surged by 30% in 2024, strengthening market revenue streams. • Imports: North American imports of advanced scanners rose 18% in 2025, supporting high-volume clinical workflows. • Use Cases: Research labs reported 45% time savings in tissue analysis using high-throughput scanners in 2024. • Nano-Indicators: Adoption of sub-micron resolution ( Key Players • Leica Biosystems • Hamamatsu Photonics • Zeiss • 3DHISTECH • Olympus Corporation • Digital Pathology Solutions • Pathology Imaging • Roche Diagnostics • Ventana Medical Systems • Invetech • Fimmic • Labcyte Inc. • Pixelgen Technologies • Bio-Optica Milano S.p.A. Get Customization on this Report: Competitive Strategies: • Leica Biosystems introduced a compact scanner in 2024, achieving a 16% uptick in market share across Europe. • Zeiss partnered with a leading academic center to deploy AI-powered slide scanners, boosting site throughput by 33%. • Olympus Corporation's pricing strategy—offering bundled software licenses—drove a 12% revenue increase in Q1 2025. Frequently Asked Questions 1. Who are the dominant players in the Digital Slide Scanners Market? Major market players include Leica Biosystems, Hamamatsu Photonics, Zeiss, and Olympus Corporation. 2. What will be the size of the Digital Slide Scanners Market in the coming years? The market size is forecast to grow from USD 170.7 Mn in 2025 to USD 397.1 Mn by 2032. 3. Which end users industry has the largest growth opportunity? Clinical research labs and large-volume pathology centers are set to capture the highest demand. 4. How will market development trends evolve over the next five years? Trends indicate rising AI integration, cloud-based slide archives, and hybrid fluorescence scanning. 5. What is the nature of the competitive landscape and challenges in the Digital Slide Scanners Market? Competition centers on resolution, throughput, software integration, and price competitiveness; supply chain constraints remain a key challenge. 6. What go-to-market strategies are commonly adopted in the Digital Slide Scanners Market? Vendors deploy bundled service contracts, academic partnerships, and scalable financing options to accelerate adoption. About Coherent Market Insights Coherent Market Insights leads into data and analytics, audience measurement, consumer behaviors, and market trend analysis. From shorter dispatch to in-depth insights, CMI has exceled in offering research, analytics, and consumer-focused shifts for nearly a decade. With cutting-edge syndicated tools and custom-made research services, we empower businesses to move in the direction of growth. We are multifunctional in our work scope and have 450+ seasoned consultants, analysts, and researchers across 26+ industries spread out in 32+ countries. Media Contact Company Name: Coherent Market Insights Contact Person: Mr. Shah Email: Send Email Phone: + 12524771362 Address: 533 Airport Boulevard, Suite 400, Burlingame, CA 94010, United States Burlingame City: Burlingame State: California Country: United States Website:
